Volvat Medisinske Senter AS

Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this.
The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month.
If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.

Hypotheses:
1. Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals.
2. Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines.
3. Biomarkers in blood and CSF and imaging findings can be used to assess severe new-onset headache after Covid-19 vaccines.
The main aim of the project is to describe the characteristics of severe new-onset headache after Covid vaccine and the treatment effects.
Secondary aim:
1. Investigate potential mechanisms and analyse biomarkers to predict treatment effects.
2. To assess at baseline and 6-month follow-up the rate of brain MRI pathology.
3. To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up
4. To assess the levels of brain specific biomarkers
5. To assess the level of blood specific biomarkers
Duration of Study participation:
* Enrollment: 24 months
* Follow-up: at 3 and 6 months after inclusion. For those with continued severe headache regular 3-month controls are planned during the study.
Total study duration 24 months